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Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial

老年急性 HFpEF 患者的身体康复 - REHAB-HFpEF 试验

基本信息

批准号：
10501900
负责人：
DALANE W KITZMAN
金额：
$ 594.4万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10501900
关键词：
Accident and Emergency department Acute Address Affect Age Attention Black Populations Blood specimen Caregivers Cessation of life Clinic Visits Clinical Cognition Data Dissemination and Implementation EFRAC Educational workshop Elderly Enrollment Ensure Event Evidence based treatment Funding Future Geography Guidelines Health Care Costs Health system Heart failure Hospitalization Impairment Institutionalization Intervention Leadership Medical Medicare claim Mental Depression Morbidity - disease rate Multicenter Trials National Heart, Lung, and Blood Institute Not Hispanic or Latino Outcome Participant Pathway interactions Patient-Focused Outcomes Patients Pharmaceutical Preparations Phase Phenotype Physical Function Physical Performance Physical Rehabilitation Physical activity Prevalence Randomized Recommendation Reporting Research Personnel Resources Structure Subgroup Syndrome Testing Time Underserved Population Vulnerable Populations Walking Woman adjudicate attentional control clinical care clinical center cohesion cost effectiveness cost estimate data repository disability experience falls follow-up frailty health care service utilization health related quality of life heart preservation high risk high risk population hospital readmission improved innovation intervention effect intervention program meter mortality multidisciplinary novel older patient older women phase II trial physical conditioning physically handicapped preservation primary endpoint primary outcome response secondary endpoint secondary outcome single-blind trial treatment as usual trend

项目摘要

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons, and is associated with marked physical disability, poor health-related quality of life (HRQOL), frequent rehospitalizations, loss of independence, high mortality, and enormous health care costs. However, most of the trials testing a wide range of medications and strategies in ADHF have been neutral. In our recently completed NIA-funded phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of Short Physical Performance Battery (+1.5 points) in older patients with ADHF. At baseline, the participants (53%) with HF with preserved ejection fraction (HFpEF), had significantly worse impairments in physical function, frailty, HRQOL, and depression than those with HF with reduced EF. They also appeared to derive greater benefit from the intervention, with ~50% larger effect sizes in physical function, frailty, HRQOL, and depression. Patients with HFpEF also appeared to have much greater reductions in rehospitalizations and death and potential for reduced medical resource use. The finding of potentially greater benefit in HFpEF is noteworthy as HFpEF is highly relevant to older persons and has the most urgent need for new treatments since it is: 1) the most common form of HF, nearly unique to older persons, and disproportionately affects older women and Black persons; 2) increasing in prevalence; 3) accepted as a geriatric syndrome; 4) associated with marked impairments in physical function and HRQOL and high rates of frailty; 5) has high morbidity and mortality which are worsening over time; and 6) has limited evidence-based treatments. The phase 3 REHAB- HFpEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized, attention-controlled, single-blinded trial will enroll 880 older adults age >60 years with ADHF and HFpEF across 20 geographically dispersed clinical centers. We will test the hypothesis that the innovative REHAB-HF intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (Aim 1) and the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of older adults, at 6-months (Aim 2). We will also assess the intervention’s impact on HRQOL, frailty, depression, physical activity, and health care costs. Our diverse, cohesive, multi-disciplinary team and experience from the phase 2 trial will ensure efficient and effective execution and dissemination. REHAB-HFpEF directly addresses the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve key outcomes that are meaningful to patients, caregivers, health systems, and payers. The trial has strong potential to change clinical guidelines, reduce health care costs, and influence national coverage decisions for the large, growing, underserved, high-risk population of older patients with acute HFpEF.

急性失代偿性心力衰竭（ADHF）是老年人住院治疗的主要原因